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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24691
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
Event Description
It was reported that entrapment of device occurred. The 99% stenosed target lesion was located in mildly tortuous and severely calcified popliteal artery. An attempt was made to wire the superficial femoral artery (sfa) with 0. 018 thruway guidewire but it was failed to cross the lesion the device was replaced with non-boston scientific (bsc) guidewire to crossed the lesion. Following pre-dilatation of a non-bsc balloon catheter, a non -bsc stent was implanted, and post-dilatation was performed with sterling balloon catheter. Since there was a lesion in popliteal artery, a non-bsc guidewire was crossed the lesion. A 3mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation. However, during the procedure, it was stuck with the non-bsc guidewire. The balloon was removed together with the guide wire. It was also noted that the device was unable to be removed from the guidewire but eventually, it was removed completely from the patient's body. The sfa which was the original target of treatment was treated without any problem, so the procedure was completed with this device. There were no patient complications nor injuries reported.
 
Manufacturer Narrative
(b)(6).
 
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Brand NameCOYOTE ES
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13907254
MDR Text Key288031844
Report Number2134265-2022-02581
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0025711630
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/25/2022 Patient Sequence Number: 1
Treatment
GUIDEWIRE USED: JUPITER; INTRODUCER SHEATH USED: DESTINATION 7FR
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